Iamesi

Leaflet accompanying the packaging: patient information

Jamesi, 50 mg + 850 mg, film-coated tablets

Jamesi, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metforminhydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Jamesi and what is it used for
• 2. Important information before taking Jamesi
• 3. How to take Jamesi
• 4. Possible side effects
• 5. How to store Jamesi
• 6. Contents of the packaging and other information

1. What is Jamesi and what is it used for

Jamesi contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body. The medicine, used in conjunction with diet and physical exercise, helps to reduce blood sugar levels. This medicine can be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Jamesi

When not to take Jamesi

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6),
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss,

Lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.

• if you have a severe infection or dehydration,
• if you are going to have a radiological examination with intravascular administration of a contrast agent. You should stop taking Jamesi during the radiological examination and for at least 2 days or more, according to your doctor's recommendations, depending on your kidney function.
• if you have recently had a heart attack or have had severe circulatory problems, such as shock or breathing difficulties,
• if you have liver disease,
• if you drink excessive amounts of alcohol (either regularly or from time to time),
• if you are breastfeeding.

You should not take Jamesi if any of the above contraindications apply to you. You should consult your doctor to determine other methods of controlling diabetes. In case of doubt, before taking Jamesi, you should discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin + metformin, cases of pancreatitis (see section 4) have been reported. If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Jamesi.

Risk of lactic acidosis

Jamesi may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Jamesi if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Jamesi and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis

because this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell along with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin, you experience any of the following symptoms: seizures, decreased cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Jamesi, you should discuss it with your doctor or pharmacist:

• if you have or have had pancreatitis (e.g., pancreatitis).
• if you have or have had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if you have type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if you have currently or in the past experienced allergic reactions to sitagliptin, metformin, or Jamesi (see section 4).
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Jamesi, as this may lead to excessive reduction of blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are going to have a major surgical procedure, you should not take Jamesi during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Jamesi. In case of doubt, before taking Jamesi, you should discuss it with your doctor or pharmacist. During treatment with Jamesi, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Jamesi and other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Jamesi before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Jamesi. You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Jamesi by your doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• diuretics (medicines that increase urine production),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Jamesi with digoxin, you should have your digoxin levels checked.

Jamesi and alcohol

You should avoid excessive alcohol consumption while taking Jamesi, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breastfeeding. See section 2, "When not to take Jamesi".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, while driving and using machines, you should take into account that dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive and use machines. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Jamesi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Jamesi

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

• You should take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• Your doctor may increase the dose of Jamesi to control blood sugar levels.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medicine, you should continue to follow the diet recommended by your doctor and pay attention to the even distribution of carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Jamesi than recommended

If you take more of this medicine than you should, you should contact your doctor immediately. You should go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Jamesi

If you miss a dose, you should take it as soon as possible. If it is almost time for your next dose, you should skip the missed dose and continue taking the medicine as usual. You should not take a double dose of this medicine.

Stopping treatment with Jamesi

To maintain control of blood sugar levels, you should take this medicine for as long as your doctor recommends. You should not stop taking this medicine without consulting your doctor first. Stopping treatment with Jamesi may lead to increased blood sugar levels. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should STOP taking Jamesi and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

Jamesi may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stoptaking Jamesi and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, you should stop taking Jamesi and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. In some patients taking metformin after starting sitagliptin, the following side effects have occurred: Common (may occur in less than 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting Uncommon (may occur in less than 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness. Some patients have experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred: Very common (may occur in more than 1 in 10 patients): low blood sugar levels Common: constipation. In some patients taking this medicine with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet. In some patients taking this medicine with insulin, the following side effects have occurred: Very common: low blood sugar levels Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin (one of the active substances of Jamesi) alone or in combination with other anti-diabetic medicines have experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, or nasal congestion and sore throat, and joint or muscle pain Uncommon: dizziness, constipation, itching. Rare: decreased platelet count. Unknown frequency: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin). Some patients taking metformin alone have experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness and tingling, or pallor or yellowing of the skin). Your doctor may order certain tests to find the cause of the symptoms you are experiencing, as some of them may also be caused by diabetes or other unrelated health problems. Very rare: liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jamesi

You should keep this medicine out of the sight and reach of children. You should not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated. You should not store it above 30°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Jamesi contains

• The active substances of Jamesi are sitagliptin and metformin.
• Jamesi, 50 mg + 850 mg: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Jamesi, 50 mg + 1000 mg: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients of the medicine are: Core - microcrystalline cellulose (type 102), povidone (K 29/32), sodium lauryl sulfate, and magnesium stearate; Coating Jamesi, 50 mg + 850 mg, film-coated tablets (Opadry QX Pink), macrogol (PEG) and polyvinyl alcohol copolymer (E1209), talc (E553b), titanium dioxide (E171), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide red (E172) Coating Jamesi, 50 mg + 1000 mg, film-coated tablets (Opadry QX Brown), macrogol (PEG) and polyvinyl alcohol copolymer (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide black (E172),

What Jamesi looks like and contents of the pack

Jamesi, 50 mg + 850 mg, film-coated tablets are oval, biconvex, approximately 20.5 mm x 9.5 mm in size, pink, with "S476" engraved on one side and smooth on the other. Jamesi, 50 mg + 1000 mg, film-coated tablets are oval, biconvex, approximately 21.5 mm x 10.0 mm in size, brown, with "S477" engraved on one side and smooth on the other. The medicinal product is packed in a cardboard box. Blisters of PVC/PVDC/Aluminum. Pack sizes: 14, 28, 56, 60, and 196 film-coated tablets. Container with HDPE with a PP closure and a desiccant. Pack size: 196 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva, k.s. U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer/Importer:

Laboratorios Liconsa S.A. Avenida Miralcampo 7 Poligono Industrial Miralcampo Azuqueca De Henares 19200 Guadalajara Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Spain: Jamesi Bulgaria: Джамези/Jamesi

For more information, you should contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:May 2025